HD drugs being held up by FDA

First was Omeros on some data from a rat study. They stopped the trial but it was never called a clinical hold by the OMEROS or the FDA. The stock fell 14% on the announcement the trial was halted.
From the Aug 10Q:
� PDE10 - OMS824 for Huntington's disease and Schizophrenia. OMS824, our lead phosphodiesterase 10, or PDE10, inhibitor, is in a Phase 2 clinical program for the treatment of Huntington's disease, in which clinical trials are currently subject to dosing limitations, and a Phase 2 clinical program for schizophrenia, in which no clinical trials are currently active. The dosing limitations in our Phase 2 clinical trial in Huntington's may potentially be removed pending generation, submission and FDA review of additional information. We are conducting nonclinical studies to generate additional data for further discussion with the FDA regarding the dosing limitations and are currently preparing for a re-designed Phase 2 clinical trial in patients with Huntington's disease. As we announced in October 2014, clinical trials evaluating OMS824 in schizophrenia are suspended currently at the request of the FDA.
https://biz.yahoo.com/e/160809/omer10-q.html

Next was the Prana PCH which needs no discussion here.

Now it is Teva. That one is puzzling. They were going for approval of the chorea drug they acquired from Auspex.

[Teva Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) answering the pharmaceutical’s New Drug Application (NDA) for SD-809 (deutetrabenazine) tablets, for the treatment ofchorea associated with Huntington’s disease (HD), a condition reported by nearly 90 percent of all Huntington’s patients at some point during the course of their disease.
Based on Teva’s deuterium technology, SD-809 (deutetrabenazine) is an investigational, oral, small-molecule vesicular monoamine 2 transporter (VMAT2) inhibitor, specifically developed for the treatment of HD-associated chorea. Deutetrabenazine had already been granted Orphan Drug Designation for the treatment of Huntington’s disease by the FDA in November 2014.
SD-809 is the first deuterated product that the FDA has reviewed. In its Complete Response Letter, the FDA asked Teva to analyze blood levels of certain metabolites, which are not novel and are similar in subjects who take either tetrabenazine or deutetrabenazine. The FDA has requested no further clinical trials.]
[“Teva will continue to work closely with the FDA to bring SD-809 to the market as quickly as possible,” said Michael Hayden, M.D., Ph.D., Teva’s president of global research and development and CSO, in a press release. “We know that many people in the HD community are waiting for this new medicine. We understand there are very limited treatment options for HD patients and their families, hence we are accelerating the re-analysis process we were asked to conduct. We plan to submit our response to the CRL [later in] 2016.”]
http://huntingtonsdiseasenews.com/2...of-chorea-associated-with-huntington-disease/

That was after a phase3 and NDA (approval) application. It was puzzling because the FDA asked for info on metabolites which are common to the already approved drug tetrabenazine.